pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. not a medical device, ii.

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FDA Law Blog

NOVEMBER 15, 2022

At DOJ, Mr. Claud prosecuted and supervised complex criminal and civil trial litigation and investigations under the Food, Drug, and Cosmetic Act, Federal Trade Commission Act, Consumer Product Safety Act, and Federal data privacy laws.

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Advarra

SEPTEMBER 8, 2022

As electronic documentation usage increases in clinical trials, organizations must make sure they’re still protecting participants’ health and safety without sacrificing quality or efficacy. One way to do so is to ensure the software platforms you are using to conduct research are in line with federal regulations. The short answer: No.

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Cloudbyz

AUGUST 9, 2023

As it becomes more complex with growing volumes of data, evolving regulations, and the pressure for faster drug development, traditional methods of clinical research management are no longer sufficient. Unified Data Management Clinical trials generate vast amounts of data, from patient records to lab results and monitoring findings.

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Camargo

DECEMBER 13, 2021

Like with small molecules, clinical trials of biologics are designed to determine pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy. The regulations regarding BLAs for therapeutic biological products are included in 21 CFR parts 600 , 601 , and 610. Expanded access to experimental biologics. BLA process (CBER).

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FDA Law Blog

JANUARY 7, 2024

A PMR is a study “that sponsors are required to conduct under one or more statutes or regulations,” whereas a PMC is a study “that a sponsor has agreed to conduct, but that are not required by a statute or regulation” (see FDA Webpage, Postmarketing Requirements and Commitments: Introduction ).

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FDA Law Blog

MAY 3, 2021

On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 C.F.R. §§ 11.10, 11.44(a).

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FDA Law Blog

JANUARY 1, 2024

Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Warning Letters, generally made public in a batch each Tuesday, are FDA’s public sanction that is most widely used to bring pressure on manufacturers and clinical trial investigators.

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pharmaphorum

JULY 16, 2021

Mesdopetam is currently in a phase 2b trial as a potential treatment option for people living with Parkinson’s who have uncontrolled involuntary movements (dyskinesias) caused by treatment with levodopa, the standard therapy for the disorder. Ipsen’s other main research areas are oncology and rare diseases.

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Velocity Clinical Research

JUNE 29, 2023

And if you don’t have the infrastructure and [a team adequately equipped] to run trials, it really is difficult to maintain doing trials.” Dr. Eder practices at Velocity’s research site in Binghamton that partners with United Health Services (UHS) to conduct clinical trials for a broad range of investigational products.

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The Pharma Data

MAY 17, 2021

Conducting clinical trials to see if a drug is safe and effective can be a very time-consuming process. To meet the urgent demand for effective therapies, FDA has worked with clinical trial experts to rapidly advance best practices in the design and execution of clinical trials. Content current as of: 05/17/2021.

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The Pharma Data

APRIL 26, 2022

Given the similar course of COVID-19 disease in adults and pediatric patients, today’s approval of Veklury in certain pediatric patients is supported by efficacy results from phase 3 clinical trials in adults. Information on the trials in adults can be found in the FDA-approved drug labeling for Veklury. Source link: [link].

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FDA Law Blog

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). at 50,040 codified at 21 C.F.R.

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FDA Law Blog

MAY 3, 2021

Butler — On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The “responsible party” is the sponsor or principal investigator of the trial. The notice was given to Acceleron Pharma, Inc., 42 C.F.R. §§ 11.10, 11.44(a). 42 U.S.C. §

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The Pharma Data

FEBRUARY 13, 2022

As part of its rolling submission, the company recently notified the agency of additional findings from its ongoing clinical trial. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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The Pharma Data

FEBRUARY 24, 2022

For today’s approval, Jardiance’s safety and effectiveness were evaluated as an adjunct to standard of care therapy in a randomized, double-blind, international trial comparing 2,997 participants who received Jardiance, 10 mg, once daily to 2,991 participants who received the placebo. Source link: [link].

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FDA Law Blog

JUNE 12, 2022

In that case, the DOJ filed a statement of interest , arguing that a violation of the Federal Food, Drug, and Cosmetic Act (FDCA) or implementing regulations may sometimes be “material to the government’s decision whether to pay for the affected product, and thus relevant in an FCA case.”.

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The Pharma Data

NOVEMBER 23, 2021

Livtencity’s safety and efficacy were evaluated in a Phase 3, multicenter, open-label, active-controlled trial that compared Livtencity with a treatment assigned by a researcher running the study, which could include one or two of the following antivirals used to treat CMV: ganciclovir, valganciclovir, foscarnet or cidofovir.

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The Pharma Data

FEBRUARY 23, 2022

The safety and efficacy of the One Male Condom was studied in a clinical trial comprised of 252 men who have sex with men and 252 men who have sex with women. When used during anal intercourse, the One Male Condom should be used with a condom-compatible lubricant. All participants were between 18 through 54 years old. Source link: [link].

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XTalks

JANUARY 25, 2023

Brenzavvy’s approval was based on an impressive amount of data collected from 23 clinical trials involving over 5,000 patients with type 2 diabetes. The Federal Food, Drug, and Cosmetic Act (FFDCA) gives the FDA the legal authority to approve drugs for both humans and animals.

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Advarra

JULY 19, 2022

The sponsor is the pharmaceutical company conducting the trial. If you mean using a different contract research organization (CRO) for the different phases of clinical trials – that’s different. Also consider CRO oversight, trial management, data handling and record keeping, as well as allocation of responsibilities.

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The Pharma Data

FEBRUARY 13, 2022

The clinical data are from a phase 2, randomized, single-dose clinical trial evaluating the efficacy of bebtelovimab alone and bebtelovimab combined with other monoclonal antibodies for treating mild to moderate COVID-19. The placebo-controlled portion of the trial enrolled 380 low-risk patients (i.e., 2 omicron subvariant.

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XTalks

JANUARY 12, 2021

The letter , which was sent on January 4, 2021, stated that several of the company’s products violated section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a) which prohibits the introduction and delivery of new drugs without the Secretary of Health of Human Service’s approval.

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FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. Karst — Earlier this week, we posted Part 1 of our three-part series on U.S. That did not happen.

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The Pharma Data

DECEMBER 31, 2020

Despite the claims from the Trump camp, multiple trials indicated that hydroxychloroquine was not effective. A trial in Brazil was also halted due to safety concerns. Zhang’s arrest was for “the suspected offense of smuggling goods prohibited by the import and export regulations under the laws of the PRC (People’s Republic of China).”

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FDA Law Blog

AUGUST 16, 2021

A PANDA, or the Pre-Hatch-Waxman Abbreviated New Drug Application, refers to abbreviated drug applications submitted and approved under sections 505(b) and 505(c) of the Federal Food, Drug, and Cosmetic Act (FDCA) prior to the enactment of the Hatch-Waxman Amendments in 1984, as FDA announced in the Federal Register last week.

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The Pharma Data

NOVEMBER 21, 2020

In a clinical trial of patients with COVID-19, casirivimab and imdevimab, administered together, were shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo. View original content to download multimedia: [link].

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The Pharma Data

NOVEMBER 6, 2020

This device was studied in a 30-day randomized, sham-controlled trial of 70 patients. A sham therapy is an inactive treatment or procedure that is intended to mimic as closely as possible a therapy in a clinical trial. Nightware is available by prescription only and is intended for home use. .

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The Pharma Data

NOVEMBER 12, 2021

The effectiveness and safety of Besremi were evaluated in a multicenter, single-arm trial that lasted 7.5 In this trial, 51 adults with polycythemia vera received Besremi for an average of about five years. Source link: [link].

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XTalks

FEBRUARY 8, 2021

While there are currently six biosimilars for AbbVie’s Humira (adalimumab) that have been approved by the regulator, the company’s patents prevent biosimilars from being launched until 2023. The regulator allows biosimilars to show slight differences in clinically inactive components of a product.

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The Pharma Data

DECEMBER 18, 2020

effective in preventing COVID-19 disease among these clinical trial participants with 11 cases of COVID-19 in the vaccine group and 185 in the placebo group. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The vaccine was 94.1% SOURCE U.S.

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Pfizer

DECEMBER 13, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act, unless the authorization is terminated or revoked sooner. IMPORTANT SAFETY INFORMATION . Antimycobacterials: rifampin. Herbal Products: St.

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Pfizer

AUGUST 15, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner. IMPORTANT SAFETY INFORMATION. Anticonvulsant: carbamazepine, primidone, phenytoin.

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Pfizer

DECEMBER 20, 2022

Results from these analyses are consistent with previously disclosed efficacy and safety data for the trials. Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor. IMPORTANT SAFETY INFORMATION. Anticancer drugs: apalutamide. Anticonvulsant: carbamazepine, phenobarbital, primidone, phenytoin.

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The Pharma Data

FEBRUARY 4, 2021

– Full-Year Global Net Revenues from the Aesthetics Portfolio Were $2.590 Billion; Global Botox Cosmetic Net Revenues Were $1.112 Billion. Global Botox Cosmetic net revenues were $493 million , an increase of 9.1 – Reports Fourth-Quarter Diluted EPS of $0.01 percent on a reported basis, or 45.0 Recorded a $4.7

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pharmaphorum

OCTOBER 4, 2022

Criteria for regulation. The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). peer-reviewed clinical studies or clinical practice guidelines) meet Criterion 2 and are not medical devices subject to FDA regulation and oversight.

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Pfizer

NOVEMBER 23, 2022

PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner. IMPORTANT SAFETY INFORMATION. Antimycobacterials: rifampin. Herbal Products: St.

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